A Randomized Clinical Trial to Assess Caries Arrest by Using Silver Diamine Fluoride in U.S. Children: Interim Findings.

Purpose: To assess the effectiveness of 38 percent silver diamine fluoride (SDF) in arresting cavitated caries lesions in young U.S. children. Methods: Children 12 to 71 months of age with severe early childhood caries participated in this phase three, multicenter, randomized, placebocontrolled trial. SDF was applied twice (at baseline and six months), and children were followed for eight months. A planned interim analysis of only the six-month primary outcome caries arrest data, for approximately half of the cohort (680 of 1,144 children), was conducted using a generalized estimating equation model, accounting for non-independence among carious lesions within a patient. Results: Five hundred ninety-nine of the 680 participants, with 1,413 lesions, completed the six-month exam. Lesions in the SDF group demonstrated 54 percent arrest versus 21 percent in the placebo (P<0.001). Conclusions: Silver diamine fluoride was effective at arresting active cavitated lesions in this population, leading to the early stop of the trial. Final analyses of all data and other outcomes are currently underway.

A Cost-Effectiveness Analysis of Population-Level Dental Caries Prevention Strategies in US Children.

OBJECTIVE: To improve oral health disparities and outcomes among US children impacted by dental caries, there is a need to understand the cost-effectiveness of a targeted, risk-based versus universal-based approach for caries prevention. METHODS: Health and economic outcomes were simulated in a cohort of 50,000 US children aged 1-18 years, comparing current practice (CP) to risk-based-prevention (RBP) and prevention-for-all (PFA) strategies using health care sector and limited societal perspectives. Prevention included biannual oral health exams and fluoride varnish application, and one-time dental sealant placement. The primary outcome is the cost-effectiveness ratio (ICER), defined as the additional cost per quality-adjusted life year (QALY) gained when comparing each strategy to the next least costly one. RESULTS: For RBP compared to CP, the ICER was US$83,000/QALY from the health care sector perspective; for PFA compared to RBP the ICER was US$154,000/QALY. Using a limited societal perspective that includes caregiver time spent attending dental or medical setting visits, RBP compared to CP yielded a ratio of $119,000/QALY and PFA compared to RBP was $235,000/QALY. Results were most sensitive to changes in the probability of pain from an episode of dental caries, costs for prevention and restoration, and the loss in health-related quality of life due to dental caries pain. Scenario analyses evaluating a reduced intensity of prevention services yielded lower ICERs. CONCLUSION: Using a risk-based approach that identifies and targets children at increased risk for dental caries to guide the delivery of prevention services represents an economic value similar to other pediatric prevention programs.

Primary Caregiver Retention and Perceptions of Retention Strategies in a 36-Month Prospective Childhood Caries Study.

INTRODUCTION/OBJECTIVES: This paper reports on participant retention from an ongoing prospective, multi-site cohort caries risk study involving parent/infant pairs. The objectives were to: (1) compare the retention rates at each intermediate contact (every 4 months) and dental visit (every 18 months) across the 3 clinical sites, (2) assess primary caregivers' perceptions at the end of the study about the retention efforts used in this longitudinal study, and (3) determine whether primary caregiver baseline demographic characteristics and child's baseline caries experience were associated with retention. METHODS: 1325 primary caregiver-child pairs recruited at the child's first birthday were followed for 36 months at 3 sites. Dental visits occurred at children's ages of approximately 12, 30, and 48 months. Telephone/email intermediate contacts with the primary caregiver occurred 6 times between dental visits. The outcome variable was the retention rates at each dental visit and each intermediate contact. Primary caregivers' perceptions of intermediate contacts were evaluated. Retention rates were compared by maternal age, race, ethnicity, Medicaid status, yearly household income, baseline caries experience (defined as decayed, missing due to caries, or filled tooth surfaces) at 12 months, and the number of teeth erupted. RESULTS: 1325 primary caregiver/infant pairs were enrolled and completed the first in-person dental visit, 1062 pairs (80%) completed the second visit and 985 (74%) completed the third. Most primary caregivers were female (94%), with a mean age of 29 years and 667 (50%) self-identified as White, 544 (41%) as Black, and 146 (11%) as Hispanic. The percentages of successful intermediate contacts were 95% at 4 months decreasing to 82% at 34 months. Almost all 964 (98%) of 985 primary caregivers reported at the last visit that they were comfortable/very comfortable with 4-month intermediate contacts. The multivariable analysis showed that primary caregivers who were older (OR = 1.07; 95% CI, 1.04-1.09) and White (OR = 1.52; 95% CI, 1.12-2.06) were more likely to complete the study. CONCLUSIONS: Retention strategies were focused on frequent routine contact and increasing monetary incentives. Those strategies may have resulted in retention exceeding the proposed goals. At the end of the study, primary caregivers were comfortable with the 4-month intermediate contacts.